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The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada: Canadian Medical Association Submission to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy11035
Date
2013-11-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-11-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the government's role in addressing prescription drug abuse in Canada. It is increasingly recognized that while prescription medication has an important role in health care, the misuse and abuse of controlled psychoactive prescription medications, notably opioids such as oxycodone, fentanyl and hydromorphone, is emerging as a significant public health and safety issue. The use of prescription opioids is on the rise, in Canada and internationally. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The CMA is particularly concerned about the impact of prescription drug abuse and misuse on vulnerable populations; notably, seniors, youth and First Nations. We note, for example, that in 2011 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. Though many patients are prescribed controlled drugs to treat medical conditions, it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Canada's physicians believe that the misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Therefore, the CMA makes the following recommendations to the Committee: 1) A National Strategy to Address the Abuse and Misuse of Prescription Medication The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA has consistently recommended a comprehensive national strategy to address the problems of drug abuse in Canada, whether of illegal or prescription-based substances. The Canadian Centre on Substance Abuse, in its report First Do No Harm: Responding to Canada's Prescription Drug Crisis, has offered nearly 60 recommendations toward the development of a strategy to combat misuse of prescription medications. The CMA believes that such a strategy should include: a) Prevention: Existing community programs and social marketing campaigns to address prescription drug abuse are generally aimed at young recreational users. For example, since many such users report that they get drugs from their parents' or friends' medicine cabinets, many jurisdictions have implemented prescription "take-back" programs, and education campaigns to promote safe storage and disposal of medications. Prevention strategies aimed at other types of prescription drug abuse, and targeting other populations such as health care providers, are still required. b) Treatment: Appropriate services for the treatment of addiction to prescription drugs are also a vital part of a national strategy. The CMA recommends that all partners work to improve and promote access to treatment programs - not only for treatment of addiction, such as pharmacological interventions, support and counselling, and withdrawal management, but also to treat and manage pain. In particular, the CMA recommends improving access to culturally appropriate treatment, counselling and withdrawal management programs in rural and remote areas, and for First Nations. c) Consumer Protection: There are several ways in which consumer protection strategies may form part of a strategy. One is modifications to the drugs themselves. For example, opioid manufacturers have developed formulations of their products intended to minimize their abuse potential, such as "slow-release" formulations and other forms of tamper-proofing to reduce a drug's potential for abuse. CMA supports further investigation into abuse-deterrent technologies. d) Surveillance and Research: Our knowledge of the extent of the prescription drug abuse problem in Canada, and the effectiveness of strategies proposed to combat it, is limited by a number of factors. These will be more specifically addressed later in this brief. 2) Strategies to Enhance Optimal Prescribing in Canada The CMA recommends that governments at all levels work with prescribers and the public, industry and other stakeholders to develop and implement a nationwide strategy to support optimal prescribing and medication use in Canada. In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA acknowledges that we have not yet achieved that ideal, but believes that optimal prescribing in Canada is a goal worth achieving. Our 2010 position statement "A Prescription for Optimal Prescribing" (Appendix A) recommends a national strategy to promote best practices in prescribing, and its recommendations can be applied to the specific situation of prescription drug abuse. Key elements of this strategy are: * Relevant, objective and easily accessible information for prescribers, which can readily be incorporated into every day practice. This can include clinical decision-support tools for use at the point of care. * Ongoing development and dissemination of clinical guidance in pain management. A Canadian practice guideline for use of opioids to treat chronic non-cancer pain, prepared under the direction of the multi-stakeholder National Opioid Use Guideline Group (NOUGG), was published in the Canadian Medical Association Journal on June 15, 2010. A number of plans for dissemination of this guideline are under way, under the direction of the Michael G. DeGroote National Pain Centre at McMaster University. They include an online CME module, co-sponsored by the CMA, which is now being finalized by MDcme.ca, a professional education group based at Memorial University. * Educational programs for prescribers in pain management and in the management of addictions. Both addiction treatment and pain management should be part of the educational curriculum in medical school and residency training as well as in continuing education. Educational programs could also provide prescribers with advice on how to recognize addiction in a patient, or on how to deal with fraudulent or aggressive patients. * Ensuring that prescribers have access to expert advice if required. This could be achieved through such means as: o Academic detailing programs, which use personalized one-on-one techniques to deliver impartial prescribing information to practitioners. o Communities of practice and clinical support networks that link practitioners with experts in the field. Experts can not only provide clinical information, but can provide mentorship and personal advice on best practices. 3) Monitoring and Surveillance of Prescription Drug Abuse The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. One of the challenges in dealing with prescription drug abuse is the incompleteness of our knowledge of the extent of the problem, or of the most effective ways to address it. This means that physicians do not have access in real time to the information they need, at the point of care. For example, except in Prince Edward Island, physicians do not have the ability to look up a patient's medical history to determine if he or she has received a prescription from another source. Prescription monitoring programs exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. Some are administered by regulatory colleges, others by governments. The CMA recommends that national standards be developed for prescription monitoring programs, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects: * It can help identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * It can help deter cross-provincial fraud. * It can help professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, it will help researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. The CMA also recommends that this system be electronic and that it be compatible with electronic medical and pharmacy record systems, and with provincial pharmaceutical databases such as British Columbia's. Provincial and territorial governments should work with the federal government and with health care providers to improve the standardization and sharing of information where appropriate. Prescription monitoring programs should be evaluated to ascertain their effectiveness in reducing misuse and abuse. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on issues related to prescription drug abuse, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. In conclusion, the Canadian Medical Association reiterates the deep concern of Canada's physicians about prescription drug abuse and misuse in this country. We are committed to enhancing optimal prescribing and to working with governments to develop and implement a strong, coherent plan of action to address this pressing national problem.
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Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations

https://policybase.cma.ca/en/permalink/policy11114
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety

https://policybase.cma.ca/en/permalink/policy11125
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
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Proposed amendments to the marihuana for medical purposes regulations

https://policybase.cma.ca/en/permalink/policy11293
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014. The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications. While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes. There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients. The CMA recommends that Health Canada further revise the proposed amendments to the Marihuana for Medical Purposes Regulations to: 1) Enable consistent and best practice oversight In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances. For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners. Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes. It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority. However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 2) Safeguard protection of privacy As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information. In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended. In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment. 3) Clarify and enforce consumer advertising requirements Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards. Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act: 3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. 9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations: 70. No person shall (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof; (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or (c) advertise in a pharmacy a preparation referred to in section 36. While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations. The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. Overview of recommendations 1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. 2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. 4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations. 5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. 6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards. List of Appendices: * Appendix A - CMA Policy Statement: Medical Marijuana * Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information * Appendix C - CMA Policy Statement: Principles Concerning Physician Information
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Opioid overdose prevention tools and services

https://policybase.cma.ca/en/permalink/policy11248
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Text
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
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CMA submission to the study of Bill C-37

https://policybase.cma.ca/en/permalink/policy13617
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Committee on Legal and Constitutional Affairs’ study of Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts.1 1 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 The CMA is deeply concerned with the opioid crisis in Canada, with unprecedented levels of harms, including overdose deaths. The crisis is taking a toll on individuals, families and communities, as well as first responders and health professionals at the front lines. The most recent BC Coroner’s Report indicates there were about 3.6 illicit drug overdose deaths per day in February 2017, an increase of 72.9% over the number of deaths in February of last year.2 Other provinces are also facing critical situations. The CMA welcomes the introduction of Bill C-37, proposed by the Minister of Health to address various portions of the Controlled Drugs and Substances Act (CDSA), among other changes. * We are particularly appreciative, given that this is part of a new federal strategy that promises to “replace the existing National Anti-Drug Strategy with a more balanced approach (…) and restores harm reduction as a core pillar of Canada’s drug policy, alongside prevention, treatment and enforcement and supports all pillars with a strong evidence base.3 This is necessary to ensure a public health approach to drug use and addiction. * For further discussion of CMA’s position on addiction, harm reduction and supervised consumption sites, as well as terminology, such as supervised consumption sites or supervised injection sites, see CMA’s submission to the Senate Standing Committee on Legal and Constitutional Affairs. Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf This proposed legislation includes various objectives, including “to prohibit the unregistered import of pill presses, and remove the exception currently placed on border officers to only open mail weighing more than 30 grams,” (…) to “make it a crime to possess or transport anything intended to be used to produce controlled substances, allow for temporary scheduling of new psychoactive substances, and support faster and safer disposal of seized chemicals and other dangerous substances.”4 CMA is supportive of actions by the federal government that advance the work at national, provincial and local levels to address the opioid crisis. Application for a Supervised Consumption Site The objective of Bill C-37 that CMA would like to provide recommendations for is the one that seeks to “simplify the process of applying for an exemption that would allow certain activities to take place at a supervised consumption site, as well as the process of applying for subsequent exemptions.5 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 The Bill proposes to repeal the 26 requirements to apply for an exemption to the CDSA, in Section 56.1, established by the Respect for Communities Act (former Bill C-26). The CMA supports the repeal, as we have repeatedly called for the withdrawal of the amendments made by former Bill C-2, and their replacement with “legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.”7 Bill C-37 proposes to replace those 26 requirements with the five elements cited in the 2011 Supreme Court of Canada unanimous ruling on Insite8, Vancouver’s supervised injection site. These elements are, “evidence, if any, on: . the impact of such a facility on crime rates, . the local conditions indicating a need for such a supervised injection site, . the regulatory structure in place to support the facility, . the resources available to support its maintenance and . expressions of community support or opposition.”9 These elements are proposed to reduce the unnecessary obstacles and burdens on local health departments and community organizations that would deter the creation of new supervised consumption sites, even when the health and safety benefits have been clearly established. Because of this cumbersome process, the BC Ministry of Health recently authorized the creation of “overdose prevention sites” in various locations where there are concerning numbers of overdose deaths, while the ministry “wait(s) for Health Canada approval of supervised consumption services”.10 This was after the creation of unsanctioned popup sites by community groups in the downtown eastside.11 Only Insite and the Dr Peter Centre operate with approved exemptions to date, with Montreal having recently received approval for three sites.12 Many other applications have been submitted for sites in Vancouver, Victoria, Toronto and Ottawa, and others are in preparation. Although a welcome reduction to only five elements, the CMA believes that these elements require more clarity, as they can be subject to interpretation, and undue influence, and could still demand unnecessary and significant time and resources on the part of provincial and local agencies. As well, the present crisis would require an expedited process that would not delay local responses to the crisis. Hence, our first recommendation is that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. Further, CMA recommends that the elements required for an application for opening a supervised consumption site proposed in Bill C-37 be more clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. The central element to be considered is that of “the local conditions indicating a need for such a supervised injection site”. Local health authorities and community organizations struggle with the issues related to drug use, including rising rates of infections, overdoses and deaths, and this is the fundamental reason to open a supervised consumption site. The regulatory structure and the resources available to support a supervised consumption site’s maintenance are issues that local health authorities deal with regularly for any health service, given the need to provide care with reduced risk of liability. The impact of a facility on crime rates is difficult to quantify before such a site is created. Further, the government must consider the experience of the many sites both in Canada and internationally, where law and order have improved in the areas surrounding those sites. The Supreme Court stated that there has been “no discernible negative impact on the public safety and health objectives of Canada during its [Insite’s] eight years of operation.”13 As well, the crime rate is not only influenced by the existence or not of a site, but by many other factors, such as unemployment and enforcement resources. A site would necessarily be located where there are high rates of drug use, for the very purpose of offering people who use drugs much needed harm reduction and support services. The last element, expressions of community support or opposition, should not represent a burden to applicants. As stated in our brief on Bill C-2, “although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites and in European countries.”14 Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication.15 Bill C-2 is an example of how this element could be interpreted. There was an extensive list of letters of opinion required, including from representatives of local police and local and provincial governments (ministers of health and public safety), chief public health officer, professional licensing authorities for physicians and for nurses, as well as reports from community consultations.16 Such a requirement represented a cumbersome and unnecessary burden. The CMA looks forward to continued collaboration with the federal government and other organizations in the development of further action as part of the much needed comprehensive approach to address the opioid crisis. Recommendations 1. The CMA recommends that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. 2. The CMA recommends that the elements required for an exemption application to the CDSA to open a supervised consumption site, proposed in Bill C-37, be clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 7 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1
Documents
Less detail

Opioid overdose prevention supplies available in publicly accessible locations

https://policybase.cma.ca/en/permalink/policy13703
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Text
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Less detail

Physician health

https://policybase.cma.ca/en/permalink/policy13739
Date
2017-10-21
Topics
Health human resources
Ethics and medical professionalism
  3 documents  
Policy Type
Policy document
Date
2017-10-21
Replaces
PD98-04 Physician health and well-being
Topics
Health human resources
Ethics and medical professionalism
Text
The term physician health encompasses the prevention and treatment of acute or chronic issues of individual physicians, as well as the optimization of interconnected physical, mental and social factors to support health and wellness.1 Attributable to a range of personal, occupational and system-level factors, physicians and learners alike are increasingly voicing distress and calling for resources and support. As a central issue for Canadian physicians, and a growing concern within the medical profession, physician ill-health is being increasingly understood as a set of risk-management practices,2 including the use of strategies rooted in organizational psychology and occupational medicine, as well as intensified oversight by professional bodies, and the integration of maintaining personal health as a core medical competency.3 Physician health, is important to the long-term sustainability of the physician workforce and health systems.4 As a quality indicator5-6 addressing the complex array of related issues is a shared responsibility of individual physicians and the systems in which they work.2,4,5 This involves efforts from individuals as well as system-level influencers, such as stakeholder groups from areas including academic medicine, medical education, practice environments, accrediting and regulatory bodies, provincial and territorial medical associations, regional and local health authorities, national medical associations and their affiliates, governments and other decision-making bodies. Meaningful, system-wide change can only occur via deliberate and concerted efforts on a national scale5 to address personal, workplace, and cultural barriers and normalize the promotion of opportunities and conditions for optimizing health and wellness. Although considerable progress has been made, it is necessary to continue working towards a more coordinated and sustained system of health promotion, illness prevention and tertiary care to build on these successes.4-5 This policy aims to provide broad, aspirational recommendations to help guide stakeholders at all levels of the health system to promote a healthy, vibrant, and engaged profession - including a healthy practice and training culture, and work environment. RECOMMENDATIONS Individual level The CMA recommends that physicians and learners: * demonstrate a commitment to physician health and well-being as part of their responsibilities under the CanMEDS Professional Role, including: Exhibiting self-awareness and managing influences on personal well-being (e.g., self-regulation and assessment, mindfulness, resilience); managing personal and professional demands for a sustainable practice throughout the career life cycle; and promoting a professional culture that recognizes, supports, and responds effectively to colleagues in need;3 * actively engage in fostering supportive work and training environments; * assume responsibility for individual actions and behaviours that may contribute to negative culture and stigma;5 * foster relationships with family and friends, as well as interests outside of medicine, and ensure sufficient rest (including time-off); and * have a family physician and visit him or her regularly for comprehensive and objective care. System level The CMA recommends that: * national-level advocacy be undertaken to address issues related to physician and learner health; * efforts to address physician health incorporate individually targeted initiatives and optimize learning and practice environments, including cultivating a healthy culture,6-7 and that stakeholders collaborate (including input from physicians and learners) to develop and promote initiatives that strengthen physician health at both the individual and system levels; * health systems adopt an understanding of their obligation to the health of physicians that is similar to the obligation of other Canadian employers to their workers (e.g., psychological safety, work hours, employee resources, standards and expectations); * policies aiming to cultivate a healthy culture be modelled, and behaviours not conducive to supporting and enabling a healthy culture dealt with in an effective manner; * physician and health system leaders acknowledge and demonstrate that physician health is a priority, and continually assess whether actions and policies align with desired values and culture;4 * physician and health system leaders be better equipped to identify and address behaviours that are symptomatic of distress (e.g., psychological) and receive more comprehensive training to address with colleagues, including within teams; * mechanisms and opportunities for physicians and learners to access existing services and programs (e.g., provincial, institutional) are maximized, and that these resources are regularly promoted and barriers to access addressed in a timely manner;5,8 * standards, processes and strategies be developed to address occupational barriers to positive health8 (at a minimum, these should address the meaningful integration of occupational and personal life, provision of resources to enhance self-care skills,4 and prioritization of opportunities for adequate rest, exercise, healthy diet and leisure;8 * wellness (including enhancement of meaning, enjoyment and engagement) be promoted, instead of an exclusive focus on reduction of harm;5 * physicians and learners be encouraged to have a family physician, and that barriers to access such care be identified and addressed; * physicians, particularly those providing primary care to other physicians, have access to training in treating physician colleagues; * physicians and learners be given reasonable access to confidential assistance in dealing with personal and professional difficulties, provided in a climate free of stigmatization; * programs and services be accessible to physicians and learners at every stage of their diagnosis and treatment, and that seeking treatment should not feel punitive or result in punitive consequences; * physicians and learners have supportive learning and work environments free of discrimination, and for processes which provide reasonable accommodations to physicians and learners with existing disabilities, while allowing for safe patient care, to be bolstered; and * practices which enable safe and effective patient care, and support workflow and efficient capture of information (e.g., electronic medical records), do not create excessive work and time burdens on physicians. Physician organizations, professional associations and health authorities The CMA recommends that: * all physicians and learners have access to a robust and effective provincial physician health program (PHP), and for long-term, sustained efforts to be made to maintain and enhance physician health, including a commitment to resourcing PHPs5 via the provision of stable funding through provincial and territorial medical associations, or the negotiation of such funding from provincial governments; * training programs, hospitals, and other workplaces ensure appropriate programs, services, and policies are developed, in-place, and enforced for physicians and learners to get help to manage health and behavioural issues, support the need for treatment, and facilitate return to work or training while protecting individual confidentiality, privacy, as well helping the institution manage risk; * the range of continuing medical education offerings aimed at personal health be expanded (content should develop individual skills and extend to training for leaders and administrators that targets improved training and practice environments and culture); * continuing education credits for physicians' efforts to enhance their personal wellness or that of colleagues be established and promoted, free of conditions requiring links to patient care; * emerging champions from learner and early-career segments be identified and supported; and * the unique health and wellness challenges faced by physicians and learners in rural, remote, or otherwise under-serviced regions (including the Canadian territories) be recognized, and for access to services and other resources to be enhanced. Medical schools, residency training programs, and accreditation bodies The CMA calls for: * accreditation standards for health and wellness programs and initiatives for medical faculties and training programs, and health authorities to be raised, reviewed in an ongoing manner and that standards and competencies be enforced; * action to bring meaningful change to the 'hidden curriculum' by aligning formal and 'hidden' curriculums that promote and reinforce positive conduct, and for accreditation bodies to consider this in their review and enforcement of standards for training programs; and * formal health and wellness curricula to be integrated and prioritized at the undergraduate and postgraduate levels, including but not limited to training around how to recognize and respond to distress or illness in oneself and colleagues, as well as self-management strategies (e.g., resilience and mindfulness). Medical regulatory authorities The CMA calls for medical regulatory authorities to: * work with provincial and territorial medical associations, PHPs, governments and other key stakeholders to; (a) create a regulatory environment that protects the public (their explicit duty) while limiting barriers for physicians seeking diagnosis and treatment,5 and (b) promote resources for early self-identification of potential health issues; and * while maintaining their duty to protect the public, review their approach to mental health challenges to ensure that focus is placed on the existence of impairment (illness interferes with ability to engage safely in professional activities,9 and not the mere presence of a diagnostic label or act of seeking of care5 (in order to ensure that physicians and learners who are appropriately caring for their health not be impacted in their ability to work). Governments The CMA calls for: * governments to acknowledge the adverse impact their policies and processes can have on the health of physicians, and to adopt and enforce health and wellness standards through a lens of occupational health for physicians that are similar to those afforded to other Canadian workers; * governments to work with employers and key stakeholders to create more effective systems that provide better practice and training conditions;5 and * enhanced support for provincial PHPs, institutions (e.g., medical schools, training programs), and other providers of physician health services.5 Researchers The CMA recommends that: * national and regional data for major health and wellness indicators be assessed at regular intervals to establish and compare norms and to better target and assess initiatives; * a national research strategy be developed through collaboration among relevant stakeholders to identify priorities, coordinate efforts, and promote innovation (consider the specific recommendations from a 2016 research summit to improve wellness and reduce burnout,10 including: Estimating economic impacts; using common metrics; developing a comprehensive framework for interventions with individual and organizational components; and sharing the best available evidence); and * further research in a range of areas including, but not limited to: efficacy of programs, strategies, and systems for promoting and managing health and wellness; examination of the factors exerting the greatest influence on physician health; and system-level interventions.5 Approved by the CMA Board of Directors October 2017 See also Background to CMA Policy on Physician Health REFERENCES 1 World Medical Association (WMA). WMA Statement on physicians well-being. France: WMA; 2015 Oct. Available: https://www.wma.net/policies-post/wma-statement-on-physicians-well-being/ (accessed 2017 Oct 30). 2 Albuquerque J, Deshauer D. Physician health: beyond work-life balance. CMAJ 2014;186:E502-503. Available: https://doi.org/10.1503/cmaj.140708 (accessed 2017 Oct 30). 3 Frank JR, Snell L, Sherbino J, Royal College of Physicians and Surgeons of Canada (RCPSC). CanMEDS 2015 physician competency framework. Ottawa: RCPSC; 2015. Available: http://canmeds.royalcollege.ca/uploads/en/framework/CanMEDS%202015%20Framework_EN_Reduced.pdf (accessed 2017 Oct 30). 4 Shanafelt TD, Noseworthy JH. Executive leadership and physician well-being: Nine organizational strategies to promote engagement and reduce burnout. Mayo Clin Proc 2017;92:129-6. Available: https://doi.org/10.1016/j.mayocp.2016.10.004 (accessed 2017 Oct 30). 5 Canadian Medical Association (CMA). Physician health matters: A mental health strategy for physicians in Canada. Ottawa: CMA; 2010. Available: https://www.cma.ca/Assets/assets-library/document/en/practice-management-and-wellness/Mentalhealthstrat_final-e.pdf (accessed 2017 Oct 30). 6 Wallace JE, Lemaire JB, Ghali WA. Physician wellness: a missing quality indicator. Lancet 2009;374:1714-21. Available: https://doi.org/10.1016/S0140-6736(09)61424-0 (accessed 2017 Oct 30). 7 Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, et al. Controlled interventions to reduce burnout in physicians: A systematic review and meta-analysis. JAMA Intern Med 2017;177:195-205. Available: https://doi.org/10.1001/jamainternmed.2016.7674 (accessed 2017 Oct 30). 8 Ruotsalainen JH, Verbeek JH, Mariné A, Serra C, Ruotsalainen JH, Verbeek JH, et al. Preventing occupational stress in healthcare workers. Sao Paulo Medical Journal 2016;134:92-92. Available: https://doi.org/10.1590/1516-3180.20161341T1 (accessed 2017 Oct 30). 9 Rondinelli RD, Genovese E, Brigham CR, American Medical Association (AMA). Guides to the evaluation of permanent impairment. Chicago: AMA; 2008. Available: https://commerce.ama-assn.org/store/catalog/productDetail.jsp?product_id=prod1160002 (accessed 2017 Oct 30). 10 Dyrbye LN, Trockel M, Frank E, Olson K, Linzer M, Lemaire J, et al. Development of a research agenda to identify evidence-based strategies to improve physician wellness and reduce burnout. Ann Intern Med 2017;166:743-4. Available: https://doi.org/10.7326/M16-2956 (accessed 2017 Oct 30). BACKGROUND TO CMA POLICY PHYSICIAN HEALTH See also CMA Policy on Physician Health In recent decades there has been growing recognition of the impact of physician health on systemic outcomes and patient-care.1,2 Physician health encompasses the prevention and treatment of acute or chronic issues of individual physicians, as well as the optimization of of interconnected physical, mental and social factors to support health and wellness.3 It is also being increasingly understood as a set of risk-management practices aimed at shifting perceptions of health from being an individual (private) matter to more of a shared resource.4 In Canada evidence for this includes the use of strategies adapted from organizational psychology and occupational medicine to change physician behaviour, as well as intensified oversight by professional bodies, and the inclusion of maintaining personal health as a core competency for physicians.4,5 Despite concerted efforts to promote and protect the health and wellness of physicians, the collective state of physician health remains a significant threat to the viability of Canada's health system.1 Physician distress is emerging as an important quality indicator in medical practice,4,6 and both individual- and system-level factors are well-established contributors to compromised physician health.2,7 As such, the advancement of a model of shared responsibility - targeting the relative roles of individual physicians and system-level influencers8 - represents a robust response to this reality. 1. The state of learner and physician health Poor health may develop before or during training and persist into medical practice. Medical school and residency training are particularly challenging times, when a myriad of competing personal and professional demands threaten learner health. In Canada, it has been reported that most students suffer from at least one form of distress over the course of their training9,10 and recent national data point to higher rates compared to their age and education-matched peers. With respect to burnout, characterized by a high level of emotional exhaustion and/or high level of depersonalization (at least weekly), overall rates are reportedly 37%.11,12 Similarly higher levels of depression, anxiety and burnout are reported among American medical students than in the general population.13 While both residents and physicians are reported to be physically healthier than the general population, their mental and social health are cause for concern.1,14 Compared with the general population, physicians are at a higher risk of experiencing adverse outcomes such as depression and burnout15,16 - the latter of which is nearly twice as common among physicians compared with workers in other fields, even after adjusting for age, sex, education level, relationship status, and work hours.17 Results from the 2017 CMA National Physician Health Survey18 showed that 49% of residents and 33% of physicians screened positive for depression, and high burnout rates were reported in 38% of residents 29% of physicians. Furthermore, although the mental health, addiction and substance-use problems, including alcohol, among physicians are not dissimilar to those in the general population, the abuse of prescription drugs (e.g., opioids) is reportedly higher.1,19 Although most physicians referred to monitoring programs have been diagnosed with substance use disorders, an increasing number are being referred for recurrent mood disorders, often stemming from workplace concerns.20,21 1.1 Contributing factors Adverse health outcomes among learners and physicians are linked to a range of contributing factors, including intrinsic ones (e.g., personality characteristics22 and other personal vulnerabilities) and extrinsic ones (e.g., excessive workloads, excessive standards of training and practice, excessive duty hours, lack of autonomy, disruptive behaviour, poor work-life integration, increasing demands with diminishing resources, systemic failures, financial issues, and the practice and training environment).2,15,23 Moreover, the management of risk that many physicians are involved with as it relates to the treatment and management of their patients can be challenging and impacts their health4. A dearth of recent data on the health status of physicians in Canada represents a critical gap in knowledge and limits future efforts to refine, select and assess initiatives. 2. Consequences 2.1. Impact on learners and physicians Compromised physician health can result in decreased personal and professional satisfaction, dysfunctional personal and professional relationships, increased attrition and increased rates of suicide and suicidal ideation.6,24,25 Perhaps most troubling, completed suicide rates among physicians are 1.4-2.3 times higher than in the general population - between 300 and 400 physicians annually in the United States.26 In Canada, suicidal ideation among physicians (including residents) has been recently reported at 19% (lifetime) and 9% (in the last year)18, while Canadian medical student data report 14% (lifetime) and 6% (in the last year).11 Overall, ideation rates are higher among both physicians and learners than in the general population.27 2.2. Impact on patient care The impact of the mental and physical health of physicians extends to the quality of care provided to patients.16,28,29 For instance, physicians suffering from burnout are reportedly two to three times more likely to report their conduct with their patients as sub-optimal.24 Indeed, physicians remain a primary source of health information for patients, and they act as both role models and health advocates.15 Characteristics of burnout (e.g., poor communication and reduced empathy) run counter to the core principles of patient-centred care,30 and physicians who maintain healthy lifestyles are more likely to focus on preventive strategies with their patients.31,32 Although deficits in physician health can negatively affect patient care, it is notable that evidence linking the health of physicians to medical errors is incomplete, if not difficult to establish. Nevertheless, studies have reported a relationship between medical error and specific adverse outcomes such as burnout.17,33 2.3 Impact on health system Issues that are associated with compromised physician health, such as reduced productivity, increased turnover, absenteeism and the likelihood of early retirement,25,34 contribute to the strained state of the health system. Given that physicians represent a significant proportion of the Canadian medical workforce, more attention must be paid to physician health if the health system is to be sustainable.2 Encouragingly, studies have shown that resources and services such as workplace wellness programs produce investment returns,35,36 such as decreases in medical leave and absenteeism2,36,37 Implementing strategies from occupational medicine are also being increasingly employed to ensure patient safety when doctors return to work after illness.4 This contributes to helping balance the need of institutions and medical regulatory agencies to minimize the risk while maximizing quality of patient care, with the desire of individual physicians to help their patients while leading healthy, fulfilling lives.4 Although there are moral grounds for addressing physician and learner ill-health, an economic case can also be made to support and guide initial and ongoing investment to address the problem.7,18 In navigating the many external challenges facing the Canadian the health system, it is critical that system-level leaders not neglect internal threats, including physician distress and dissatisfaction6,7, and challenges in navigating complex work environments.24 To this end, although there are many positive and supportive elements within medical culture, it is also important to acknowledge aspects that contribute to poor health. 2.4 Impact on the culture of medical practice and training and on the workplace Enduring norms within the culture of medicine are directly contributing to the deterioration of the health of Canadian learners and physicians.2 Culturally rooted impediments, such as the reluctance to share personal issues or admit vulnerability, discourage the medical profession from acknowledging, identifying and addressing physician health issues.7 Physicians and learners alike face pressure not to be ill, to care for patients regardless of their personal health and even to attempt to control their own illness and treatment by self-medicating.1,38 Indeed, physicians are often portrayed as being invincible professionals who put patient needs above all else, including their own needs.39,40 Although the CMA Code of Ethics encourages physicians to seek help from colleagues and qualified professionals when personal or workplace challenges compromise patient care41 physicians tend to delay or avoid seeking treatment, especially for psychosocial or psychiatric concerns. Moreover, nearly 33% of Canadian physicians are not registered with a family physician.42 which means they are among the lowest users of health services.43 Providing care to physician colleagues is both complex and challenging, yet this is an area where formal training has not been explicitly or systematically provided on a national scale.1 There is a need to identify physicians willing to treat colleagues, to develop or adapt existing approaches that encourage help-seeking and to help physicians to navigate the treatment of colleagues. Stigma around mental health within medical practice and training acts as a significant barrier to early intervention.1,44 In a localized study of Canadian physicians, 18% reported distress, but only 25% considered getting help and only 2% actually did.39 Similarly, national CMA data reported that 'feeling ashamed to seek help' was identified (76%) as a major reason for physicians not wanting to contact a physician health program.18 Indeed, common concerns include not wanting to let colleagues or patients down, believing seeking help is acknowledging weakness, being apprehensive about confidentiality, and fearing negative reprisals (e.g., from colleagues, supervisors, regulatory bodies, other licence-granting bodies, insurers)1,45 Fear of retribution is also a frequent reason why physicians may feel hesitant to report impaired colleagues, even if supportive of the concept.46 From the outset of training, medical learners are introduced to system-wide cultural aspects and values of the medical profession, which they then internalize and pass on to others.2 Extensive literature on the "hidden curriculum" points to a performance culture that includes norms such as the view that adversity is character building and the valorization of emotional repression (e.g., mental toughness).2,47 Culture-related issues are being increasingly addressed as a function of medical professionalism. For instance, commitment to physician health, collegiality and support have been established as key competencies within the Professional Role of the CanMEDS Framework,5 the most widely accepted and applied physician competency framework in the world.48 This involves a commitment to exhibiting self-awareness and managing influences on personal well-being and professional performance; managing personal and professional demands for a sustainable practice throughout the physician life cycle, and promoting a professional culture that recognizes, supports, and responds effectively to colleagues in need. In support of these commitments to personal care, physicians must develop their capacity for self-assessment and monitoring, mindfulness and reflection, and resilience for sustainable practice.5 Intra-professionalism, characterized by effective clinical and personal communication among physicians,49 significantly influence job satisfaction, which in turn has been shown to predict physician health outcomes.50 Furthermore, peer support can buffer the negative effects of work demands;39 collegial, professional environments are known to be healthier for both providers and patients.51 Conversely, unprofessional behaviour is associated with physician dissatisfaction,50 and dysfunctional workplaces and poor collegiality are linked to burnout.52 Unprofessional workplace behaviour is tolerated, and in fact is often customary, within medical training and practice environments.53 Of particular concern, such behaviour carried out by more senior physicians has been shown to encourage similar conduct among learners,54 highlighting the importance of promoting effective professional role modelling.55 Unfortunately, poor supervisory behaviour, and even mistreatment of learners, is common within the medical training environment.56 Although expectations for professional behaviour are increasingly being incorporated into both undergraduate and postgraduate teaching, issues related to a lack of professionalism persist in both training and practice.51 System-wide efforts are needed to counter what is perceived to be an eroding sense of collegiality and to promote professionalism as a way to address physician burnout and enhance engagement.7,39 3. Treatment and preventive approaches 3.1 Physician health services The scope of physician health services has expanded from focusing primary focus on identifying treating and monitoring physicians with substance abuse issues to more recent efforts to de-stigmatize poor physician health and integrate proactive resources to complement tertiary approaches.1 In Canada, there are multiple services to support the health needs of learners and physicians. These can be conceptualized along a continuum of approaches,1 including the following: health-promoting environments (e.g., efforts to ensure balanced workloads, provide more support staff, and encourage physicians to make sure they get adequate exercise, nutrition and sleep in training and practice); primary prevention (e.g., resilience training, stress-reduction groups, fatigue management programs, strategies to enhance teamwork and collaborative care); secondary prevention (e.g., access to assessment and counselling; services and workshops on coping with adverse events, litigation and career transitions and on managing difficult behaviour); and tertiary prevention (e.g., more intensive outpatient counselling, inpatient treatment). Many of these approaches, including those at the system level, focus on assisting the individual physician rather than addressing more contextual issues. Most jurisdictions in Canada have consolidated a number of services under the banner of a provincial physician health program (PHP).These range from counselling, treatment and/or peer support to fitness-to-practice and return-to-work assessments, workplace behaviour management and relationship management. The services available to physicians in a given area vary greatly.1,15 More established and resourced programs often offer services across the continuum, while less established programs tend to focus on secondary and tertiary services.2 Provincial PHPs have been shown to produce positive outcomes1,20,21,48 and are generally considered to be effective in addressing user issues,57 however but many physicians remain reluctant to access them.58 In addition to provincial programs, many learners and physicians in Canada can access support and treatment from other sources, including medical school and faculty wellness programs, employee assistance or workplace programs, and more individual-led options such as physician coaches.1 There has been a steady accumulation of evidence on the positive returns of workplace health and wellness programs,35 as well as indications that even modest investments in physician health can make a difference.17 In response to challenges posed by the considerable diversity in the organizational structure of provincial PHPs, the ways in which PHPs classify information, the range of services they offer, the mechanisms of accountability to stakeholders and the manner in which they pursue non-tertiary activities (e.g., education and prevention work)59 a consortium of PHPs released a preliminary Descriptive Framework for Physician Health Services in Canada in 2016. Through this framework a series of core services (and modes of activity within each) were defined.59 Potential users of the framework include PHPs, academic institutions, medical regulators, national associations, hospitals and health authorities, as well as other local groups. The framework may serve a range of purposes, including program reviews and planning, quality improvement, resource allocation, advocacy, stakeholder consultation and standards development.59 Initiatives such as this framework help address a persistent gap in Canada around equity of and access to services. Overall, fulfilling the needs of all learners and physicians through enhanced service quality and functional equivalence is an ongoing challenge for provincial PHPs and other service providers, and it must be a priority moving forward. 3.2 Individual primary prevention Prevention and promotion activities can help mitigate the severity and decrease the incidence of adverse outcomes associated with physician health issues among learners and physicians.3 Although secondary and tertiary services are critical components of any health strategy, complementary, proactive, preventive initiatives promote a more comprehensive approach. Some of the best-documented strategies include attuning to physical health (e.g., diet, exercise, rest), psychosocial and mental health (e.g., mindfulness and self-awareness, resilience training, protecting and maintaining cultural and recreational interests outside of medicine, and protecting time and relationships with family and friends).60 For instance, resilience has been identified as an indicator of physician wellness61 and as a critical skill for individuals working in health care environments.39 Innovative, coordinated approaches such as resilience and mindfulness training are instrumental in helping physicians overcome both anticipated and unexpected difficulties, to position them for a sustainable career in medicine. Many internal (e.g., personal) and external (e.g., occupational) factors can interfere with a physician's capacity to consistently maintain healthy lifestyle behaviours and objectively attend to personal health needs. Although the emergence of individually targeted proactive and preventive activities is encouraging, a greater focus on system-level initiatives to complement both proactive and tertiary approaches is needed. This also aligns with recent CMA member data indicating that medical students (61%), residents (55%), physicians (43%) and retired physicians (41%) want more access to resources to ensure their emotional, social and psychological well-being.62 Such an approach is increasingly important in light of physicians' professional responsibility to demonstrate a commitment to personal health.5 4. Physician health as a shared responsibility Although physicians are a critical component of Canadian health systems, those systems do not necessarily promote health in the physician community. It cannot be overstated that many health challenges facing learners and physicians are increasingly systemic in nature.1 Despite increasing challenges to the cultural norm that health-related issues are an individual-physician problem,2 system-level factors are often ignored.1,7 Although solutions targeted at the individual level (e.g., mindfulness and resilience training) are important proactive approaches and are a common focus, they often do not address occupational and organizational factors.7 Intervention exclusively at the individual level is unlikely to have meaningful and sustainable impacts. Interventions targeting individual physicians are likely most effective when paired with efforts to address more systemic (e.g., structural and occupational) issues.63 Moreover, organization-directed interventions have been shown to be more effective in reducing physician burnout than individual-directed interventions, and meaningful reductions in negative outcomes have been linked to system-level interventions.22,34 Concerted efforts at the system level will ultimately drive substantive, meaningful and sustainable change. This includes coordination among leaders from national, provincial and local stakeholders as well as individual physicians.16,22,64 Potential influencers include medical schools and other training programs, regulatory bodies, researchers (and funding bodies), professional associations and other health care organizations, as well as insurers.1 Indeed, addressing the complex array of issues related to physician health is a shared responsibility. A clear mandate exists to guide individuals and leaders in promoting and protecting the health of learners and physicians.1,7 5. Conclusion Physician health is a growing priority for the medical profession. Medical practice and training present complex occupational environments34, in which leaders play a central role in shaping training, practice and organizational culture through the implicit and explicit ways in which they communicate core values.2 When promoting physician health across the career lifecycle it is also important to consider the unique challenges and experiences of physicians who are not actively practicing (e.g., on leave; have non-clinical roles) as well as those who are retired. Notwithstanding the impact on patient care or health systems, promoting the health of individual physicians and learners is in and of itself worthy of attention. Indeed, leaders in the health system have a vested interest in helping physicians to meet the personal and professional challenges inherent in medical training and practice as well as in promoting positive concepts such as wellness and engagement.7 The increasingly blurred lines between physician health, professionalism and the functioning of health systems40 suggest that leaders at all levels must promote a unified and progressive vision of a healthy, vibrant and engaged physician workforce. This involves championing health across the career life cycle through advocacy as well as promoting solutions and outcomes through a lens of shared responsibility at both individual and system levels. Broad solutions skewed towards one level, without requisite attention given to the other level, are unikely to result in meaningful change. Moving from rhetoric to action, this next frontier integrates the promotion of self-care among individuals, support for healthy and supportive training and practice environments - both physical and cultural - as well as continued innovation and development of (and support for) physician health services. This constellation of efforts will ultimately contribute to the success of these actions. October 2017 See also CMA Policy on Physician Health REFERENCES 1 Canadian Medical Association (CMA). Physician health matters: A mental health strategy for physicians in Canada. Ottawa: CMA; 2010. Available: https://www.cma.ca/Assets/assets-library/document/en/practice-management-and-wellness/Mentalhealthstrat_final-e.pdf (accessed 2017 Oct 30). 2 Montgomery AJ. The relationship between leadership and physician well-being; A scoping review. Journal of Healthcare Leadership 2016;55:71-80. 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Available: https://doi.org/10.1001/jamainternmed.2016.7674 (accessed 2017 Oct 30). 35 Chenevert D, Tremblay MC. Analyse de l'efficacité des programmes d'aide aux employés : Le cas du PAMQ. Montreal: HEC Montreal; 2016. Available: http://www.professionsante.ca/files/2016/07/Rapport-Chenevert-VF.pdf (accessed 2017 Oct 30). 36 Morneau Shepell Ltd. Workplace mental health priorities report 2015. Toronto: Morneau Shepell Ltd.; 2015. Available: https://www.morneaushepell.com/ca-en/insights/workplace-mental-health-priorities-report (accessed 2017 Oct 30). 37 Baicker K, Cutler D, Song Z. Workplace wellness programs can generate savings. Health Aff (Millwood) 2010;29:304-11. Available: https://doi.org/10.1377/hlthaff.2009.0626 (accessed 2017 Oct 30). 38 Harrison J. Doctors' health and fitness to practise: The need for a bespoke model of assessment. Occup Med (Lond) 2008;58:323-7. Available: https://doi.org/10.1093/occmed/kqn079 (accessed 2017 Oct 30). 39 Wallace JE, Lemaire J. On physician well being-you'll get by with a little help from your friends. Soc Sci Med 2007;64:2565-77. Available: https://doi.org/10.1016/j.socscimed.2007.03.016 (accessed 2017 Oct 30). 40 Lesser CS, Lucey CR, Egener B, Braddock CH, Linas SL, Levinson W. A behavioral and systems view of professionalism. JAMA 2010;304:2732-7. Available: https://doi.org/10.1001/jama.2010.1864 (accessed 2017 Oct 30). 41 Canadian Medical Association (CMA). CMA code of ethics. Ottawa: CMA; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/PD04-06-e.pdf (accessed 2017 Oct 30). 42 ePhysician Health. Primary care: Physician patient module. Ottawa: ePhysician Health; 2017. Available: http://ephysicianhealth.com/ (accessed 2017 Oct 30). 43 Sibbald B, Bojke C, Gravelle H. National survey of job satisfaction and retirement intentions among general practitioners in England. BMJ 2003;326:22. 44 Thompson WT, Cupples ME, Sibbett CH, Skan DI, Bradley T. Challenge of culture, conscience, and contract to general practitioners' care of their own health: qualitative study. BMJ 2001;323:728-31. 45 Schwenk TL, Davis L, Wimsatt LA. Depression, stigma, and suicidal ideation in medical students. JAMA 2010;304:1181-90. Available: https://doi.org/10.1001/jama.2010.1300 (accessed 2017 Oct 30). 46 DesRoches CM, Rao SR, Fromson JA, Birnbaum RJ, Iezzoni L, Vogeli C, et al. Physicians' perceptions, preparedness for reporting, and experiences related to impaired and incompetent colleagues. JAMA 2010;304:187-93. Available: https://doi.org/10.1001/jama.2010.921 (accessed 2017 Oct 30). 47 Gaufberg EH, Batalden M, Sands R, Bell SK. The hidden curriculum: what can we learn from third-year medical student narrative reflections? Acad Med 2010;85:1709-16. Available: https://doi.org/10.1097/ACM.0b013e3181f57899 (accessed 2017 Oct 30). 48 Dupont RL, Skipper GE. Six lessons from state physician health programs to promote long-term recovery. J Psychoactive Drugs 2012;44:72-8. Available: https://doi.org/10.1080/02791072.2012.660106 (accessed 2017 Oct 30). 49 Beaulieu M-D, Samson L, Rocher G, Rioux M, Boucher L, Del Grande C. Investigating the barriers to teaching family physicians' and specialists' collaboration in the training environment: a qualitative study. BMC Med Educ 2009;9:31. Available: https://doi.org/10.1186/1472-6920-9-31 (accessed 2017 Oct 30). 50 Van Ham I, Verhoeven AAH, Groenier KH, Groothoff JW, De Haan J. Job satisfaction among general practitioners: a systematic literature review. Eur J Gen Pract 2006;12:174-80. Available: https://doi.org/10.1080/13814780600994376 (accessed 2017 Oct 30). 51 Bahaziq W, Crosby E. Physician professional behaviour affects outcomes: a framework for teaching professionalism during anesthesia residency. Can J Anaesth 2011;58:1039-50. Available: https://doi.org/10.1007/s12630-011-9579-2 (accessed 2017 Oct 30). 52 Cydulka RK, Korte R. 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Non-prescription availability of low-dose codeine products

https://policybase.cma.ca/en/permalink/policy13734
Date
2017-11-7
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-11-7
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Submission to the Health Canada consultation on the potential risks, benefits and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part I1 for interested stakeholders to provide comments on the potential risks, benefits, and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only. Codeine is a widely used narcotic analgesic in Canada - low dose formulations are currently sold without a prescription, when in combination with at least two other medications. It is not available for self-selection, but kept behind the counter in pharmacies. However, serious concerns have been raised about the safety of this practice in recent years.2,3,4 A literature review examining over the counter medicine abuse in several countries found that "there is a recognized problem internationally involving a range of medicines and potential harms," including codeine-based medicines.5 Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use, including codeine. Codeine is considered to be "a poor analgesic in its own right," for which there are more suitable alternatives.6 In addition, genetic factors can substantially affect the metabolism of codeine into morphine, resulting in concentrations that vary from person to person. This can lead to potentially serious consequences, even at conventional doses, particularly in children.2 Codeine has the potential for dependence. Studies show an increase in non-therapeutic use of codeine, including over the counter formulations, leading to increases in morbidity and mortality as well as social costs. 7,8,9 An Australian study noted that "codeine-related deaths (with and without other drug toxicity) are increasing as the consumption of codeine-based products increases."10 Ontario data shows that over 500 people began methadone treatment for non-prescription codeine, between 2011 and 2014.3 In addition, over the counter codeine is often combined with acetaminophen or ASA, which also present concerns in terms of toxicity, particularly in higher doses. A review of the process examining the problems related to codeine-based over the counter formulations in Australia, New Zealand, and the United Kingdom found that each of their respective committees had decided, based on the existing evidence, "to minimize harm by using regulatory levers to restrict availability."11 Many European countries have also implemented a prescription-only status for products containing codeine, as well as some U.S. States. Some Canadian hospitals have removed codeine from their formularies, and Manitoba ended the over the counter sales last year12. Given this reality and, as part of the CMA's advocacy to reduce the harms related to opioid use, the CMA supports the requirement that all products containing codeine be sold by prescription only, as this is both a public health and a patient safety issue. Moving codeine to prescription-only will enable limiting its use and closer monitoring of patients with the view of preventing harms.10 A challenge for policy makers and prescribers is to ensure patients still have access to treatments that are appropriate for their clinical conditions.13 At the same time, we recognize that there could be unintended consequences when moving low-dose codeine to prescription-only status, particularly for those who have come to depend on its availability over-the-counter. Some may choose to seek out illicit markets for these products or purchase other, more powerful, narcotics as a substitute. Authorities must develop educational tools to inform people about less-harmful pain-relief options. As well, a reasonable timeframe for implementation of this measure should be given to allow for patients to find appropriate alternatives. The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.14 1 Controlled Drugs and Substances Act: Notice to interested parties - Non-prescription availability of low-dose codeine products. Canada Gazette Part I. 2017 Sep 09, 151(36). Available: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-09-09/html/notice-avis-eng.php#ne3 (accessed 2017 Nov 07). 2 MacDonald N, MacLeod SM. Has the time come to phase out codeine? Can Med Assoc J 2010;182(17):1825. Available: https://doi.org/10.1503/cmaj.101411 (accessed 2017 Nov 07). 3 Yang J, Zlomislic D. Star investigation: Canada's invisible codeine problem. The Toronto Star. Jan. 17, 2015. Available: https://www.thestar.com/news/canada/2015/01/17/star-investigation-canadas-invisible-codeine-problem.html (accessed: 2017 Nov 7). 4 MacKinnon, JIJ. Tighter regulations needed for over-the-counter codeine in Canada. Can Pharm J Rev Pharm Can, 2016;149(6):322-4. Available: http://www.cmaj.ca/content/182/17/1825 (accessed 2017 Nov 07). 5 Cooper RJ. Over-the-counter medicine abuse - a review of the literature. J Subst Use, 2013 Apr;18(2):82-107. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3603170/pdf/JSU-18-82.pdf (accessed: 2017 Oct 23). 6 Vagg M. Four reasons why codeine should not be sold without a prescription. The Conversation. Apr. 30, 2015. Available: http://theconversation.com/four-reasons-why-codeine-should-not-be-sold-without-prescription-41025 (accessed: 2017 Oct 23). 7 Nielsen S, Cameron J, Pahoki S . Over the counter codeine dependence final report 2010. Victoria: Turning Point, 2010. Available: http://atdc.org.au/wp-content/uploads/2011/02/OTC_CODEINE_REPORT.pdf (accessed 2017 Nov 07). 8 Fischer B, Ialomiteanu A, Boak A, et al. Prevalence and key covariates of non-medical prescription opioid use among the general secondary student and adult populations in Ontario, Canada. Drug Alcohol Rev 2013;32(3):276-87. 9 Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend 2006 Feb 01;81(2):103-7. 10Roxburgh A. et. al. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust 2015; 203(7): 299 11 Tobin CL, Dobbin M, McAvoy B. Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom. N Z J Public Health 2013 Oct. 37(5): 483-488. Available: http://onlinelibrary.wiley.com/doi/10.1111/1753-6405.12099/abstract (accessed: 2017 Nov 7). 12 Zlomislic, D. & Yang, J. The Toronto Star. Jan 12, 2016. Available: https://www.thestar.com/life/health_wellness/2016/01/13/manitoba-sets-new-rule-limiting-codeine.html (accessed: 2017 Nov 7). 13 Canadian Medical Association. Opening Statement addressing the opioid crisis to the House of Commons Standing Committee on Health. Ottawa: The Association; 2016 Oct. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/hesa-opioid-study-opening-remarks-oct-18-2016-e.pdf (accessed: 2017 Nov 7). 14 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2017 Nov 7).
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